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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 939-704-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 944.55 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7 934 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose inhalation toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 669.64 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 33.6
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose dermal toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Source information for DNELS:
- A key oral 28-day dietary toxicity with registered substance (test item containing 35% active ingredient) in rats was performed at systemic dose levels of 0.05, 0.25 and 1.25% in the diet (as solids), corresponding to 48, 254 and 1225 mg act.ingr./kg bw/day. There were no adverse effects observed, therefore the dose of 1225 mg/kg can be considered as NOAEL.
- Oral 90-day dietary toxicity studies with registered substance (test item containing 35% active ingredient) were performed in rats at systemic dose levels of 0.5, 2 and 8 (reduced to 4) g act. ingr./kg bw/day (key study) and in dogs at 0.062, 0.250 and 1 g act. ingr. /kg bw/day (supporting study) . In rats, 2 and 8 (4) g act.ingr./kg bw/day were toxic, as demonstrated by decreased body weight and food consumption, serum changes, organ-to-body weight decreases and renal disease; the dose of 500 mg/kg bw/day can be considered as NOAEL. The dog study was considered to be less appropriate as the animals were very young and sensitive to gastro-intestinal irritation, although the study did not show systemic toxicity up to 1000 mg/kg bw/day.
- A justification for calculation of DNELs is attached.
Qualitative
assessment
Only
systemic long term exposure values for worker and general population
were calculated, because no concrete values (like NOAEL, LOAEL etc) are
available from acute or irritation studies. The study design of the test
conducted assessing the acute and local toxicity does not allow in
general the derivation of local or acute DNELs, as most of the tests
were, for example, conducted as limit tests due to animal welfare.
Therefore a qualitative risk assessment for irritation is performed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 279.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA and ERASM factors
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 913 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose inhalation toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 401.79 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A key oral 90-day toxicity study is available; there was no repeated-dose dermal toxicity study.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.93 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodynamic differences between species; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies).
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Source information for DNELS:
- A key oral 28-day dietary toxicity with registered substance (test item containing 35% active ingredient) in rats was performed at systemic dose levels of 0.05, 0.25 and 1.25% in the diet (as solids), corresponding to 48, 254 and 1225 mg act.ingr./kg bw/day. There were no adverse effects observed, therefore the dose of 1225 mg/kg can be considered as NOAEL.
- Oral 90-day dietary toxicity studies with registered substance (test item containing 35% active ingredient) were performed in rats at systemic dose levels of 0.5, 2 and 8 (reduced to 4) g act. ingr./kg bw/day (key study) and in dogs at 0.062, 0.250 and 1 g act. ingr. /kg bw/day (supporting study) . In rats, 2 and 8 (4) g act.ingr./kg bw/day were toxic, as demonstrated by decreased body weight and food consumption, serum changes, organ-to-body weight decreases and renal disease; the dose of 500 mg/kg bw/day can be considered as NOAEL. The dog study was considered to be less appropriate as the animals were very young and sensitive to gastro-intestinal irritation, although the study did not show systemic toxicity up to 1000 mg/kg bw/day.
- A justification for calculation of DNELs is attached.
Qualitative
assessment
Only
systemic long term exposure values for worker and general population
were calculated, because no concrete values (like NOAEL, LOAEL etc) are
available from acute or irritation studies. The study design of the test
conducted assessing the acute and local toxicity does not allow in
general the derivation of local or acute DNELs, as most of the tests
were, for example, conducted as limit tests due to animal welfare.
Therefore a qualitative risk assessment for irritation is performed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.